Medical device and IVD consulting
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Medical device and IVD consulting
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    • Clinical Performance Study, ISO 20916
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Downloads

White Papers (Language: English)

  • 510k White Paper - thinqbetter GmbH - 07-2020

Regulations and Directives (Language: English)

  • MDR - (EU) 2017/745 with bookmarks - Consolidated version from 04-2020
  • MDD - 93/42/EEC - Consolidated version from 10-2007

  • IVDR - (EU) 2017/746 with bookmarks - Consolidated version from 10-2017
  • IVDD - 98/79/EEC - Consolidated version from 01-2012

Verordnungen und Richtlinien (Sprache: Deutsch)

  • MDR - (EU) 2017/745 mit Lesezeichen - Konsolidierte Version von 04-2020
  • MDD - 93/42/EEC - Konsolidierte Version von 10-2007

  • IVDR - (EU) 2017/746 mit Lesezeichen - Konsolidierte Version von 10-2017
  • IVDD - 98/79/EEC - Konsolidierte Version von 01-2012

Sitemap

  • Biological evaluation
  • Clinical evaluation
  • Clinical performance studies, ISO 20916
  • Performance evaluation
  • MDSAP
  • PRRC under Article 15
  • Regulatory Affairs
  • Risk management
  • Quality management
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Operator

  • thinqbetter GmbH
  • Hongkongstraße 6
    20457 Hamburg, Germany
  • Commercial Reg. HRB 159645
    VAT No. DE326776751
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Representatives

  • Lukas Losigkeit (CEO)
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